A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence
Information source: Denver Research Institute
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Cocaine Dependence
Intervention: Aripiprazole (Drug); Perphenazine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Paul Saenger Official(s) and/or principal investigator(s):
Thomas P Beresford, MD, Principal Investigator, Affiliation: Denver Veteran's Affairs Medical Center
Overall contact:
Jennifer Ratzlaff, MA, Phone: 303-399-8020, Ext: 3855, Email: Jennifer.Ratzlaff@ucdenver.edu
Summary
The purpose of this study is to gather systematic clinical data on whether aripiprazole, a
partial dopamine agonist, beneficially affects schizophrenia plus cocaine dependence
subjects. Since aripiprazole has established effects against schizophrenia, the study
focuses on whether aripiprazole concurrently reduces co-morbid cocaine dependence in
schizophrenia plus cocaine dependence sufferers compared to a standard typical antipsychotic
treatment (perphenazine). The working hypothesis states that subjects in the aripiprazole
treatment arm of the study will give fewer cocaine positive urine specimens as compared to
the perphenazine control arm.
Clinical Details
Official title: A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: The proportion of negative urine drug screen results will be significantly greater in the subjects treated with aripiprazole than in those treated with perphenazine.
Secondary outcome: The mean total self-report cocaine use days will be significantly fewer in subjects treated with aripiprazole than in those treated with perphenazine.The mean cocaine craving scores will be lower in subjects treated with aripiprazole than in those treated with perphenazine.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Have a primary DSM-IV diagnosis of Schizophrenia or Schizoaffective disorder
2. Have a DSM-IV diagnosis of current cocaine dependence.
3. Are capable of reading, comprehending, and signing informed consent.
4. Agree to take Aripiprazole or Perphenazine as treatment for SCHZ and CD.
5. Agree to stop taking any other antipsychotic medication
6. If female and of child bearing potential (WOCBP) agree to use an acceptable form of
birth control and have a negative pregnancy test within 2 days prior to starting
study medication
Exclusion Criteria:
1. Under 18 years old or over 65 years old.
2. Refusal or inability to give informed consent,
3. Have a history of myocardial infarction or ischemic heart disease, heart failure or
conduction abnormalities, cerebrovascular disease, or conditions that would
predispose to hypotension (dehydration, hypovolemia),
4. A history of seizures or conditions that lower the seizure threshold
5. Have current suicidal ideation (history of suicide attempt in past 60 days)
6. Are actively psychotic which in the opinion of the investigator would preclude proper
informed consenting or protocol adherence
7. Are receiving or plan to receive an agent metabolized by the Cytochrome P450-3A4 or
- 2D6 systems, including carbamazepine, ketoconazole, quinidine, fluoxetine, and
paroxetine
8. WOCBP not on, or do not agree to use an acceptable form of contraception
9. Known sensitivity to aripiprazole or perphenazine
10. A diagnosis of current or past tardive dyskinesia
11. Pending legal charges or a court mandate for drug treatment
12. Currently taking concomitant medications that have been shown to reduce cocaine use,
such as disulfiram
13. Clinically significant liver function abnormalities
14. Currently receiving depot neuroleptics
Locations and Contacts
Jennifer Ratzlaff, MA, Phone: 303-399-8020, Ext: 3855, Email: Jennifer.Ratzlaff@ucdenver.edu
Veteran's Affairs Medical Center, Denver, Colorado 80220, United States; Recruiting
Lori Clapp, RN, MS, Phone: 720-854-4200
Additional Information
Starting date: August 2008
Last updated: September 6, 2012
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